Pharmacokinetics/Pharmacodynamics of Albiglutide

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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

The enrollment number reflects the 283 participants starting the Multiple-dose Phase.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

This study was comprised of a Screening Period (up to 2 weeks), a Run-in Period (4 weeks), a Treatment Period (TP: 17 weeks), and a Follow-up (8 weeks) Period. The TP had a Single-dose Phase (Bioequivalence [BE] Phase: 28 days) and a 12-week Multiple-dose Phase. In the BE Phase, 186 participants were randomized; 167 received >=1 treatment dose.

Reporting Groups

Description

Albiglutide Process 2

During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.

Albiglutide Process 3

During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.

Participant Flow for 3 periods

Period 1: Single-dose Phase (BE Phase: 28 Days)

Albiglutide Process 2

Albiglutide Process 3

STARTED

86

81

COMPLETED

82

79

NOT COMPLETED

4

2

Withdrawal by Subject

2

1

Persistent Hyperglycemia

1

1

Physician Decision

1

0

Period 2: Multiple-dose Phase (MDP) (Overall)

Albiglutide Process 2

Albiglutide Process 3

STARTED

141 [1]

142 [1]

COMPLETED

125

126

NOT COMPLETED

16

16

Adverse Event

2

2

Noncompliance

0

2

Lost to Follow-up

0

2

Withdrawal by Subject

5

2

Physician Decision

2

1

Withdrawn Due to Hyperglycemia

7

7

[1]

After completion of the BE Phase, additional participants were randomized to the Overall Phase.

Period 3: Follow-up Phase (FUP) (8 Weeks)

Albiglutide Process 2

Albiglutide Process 3

STARTED

141 [1]

142 [1]

COMPLETED

138

138

NOT COMPLETED

3

4

Noncompliance

1

0

Lost to Follow-up

0

4

Withdrawal by Subject

1

0

Hyperglycemia

1

0

[1]

All participants who started the MDP entered the FUP, regardless of MDP completion status.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Albiglutide Process 2

During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.

Albiglutide Process 3

During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.

Total

Total of all reporting groups

Baseline Measures

Albiglutide Process 2

Albiglutide Process 3

Total

Overall Participants Analyzed [Units: Participants]

141

142

283

Age [1] [Units: Years]Mean (Standard Deviation)

52.6 (11.18)

54.4 (10.53)

53.5 (10.88)

[1]

Baseline data are reported for participants randomized to the Single- and Multiple-dose Phases (Overall).

Gender [1] [Units: Participants]Count of Participants

Female

78 55.3%

76 53.5%

154 54.4%

Male

63 44.7%

66 46.5%

129 45.6%

[1]

Baseline data are reported for participants randomized to the Single- and Multiple-dose Phases (Overall).

Race/Ethnicity, Customized [1] [Units: Participants]

African American/African Heritage

15

20

35

American Indian or Alaskan Native

0

1

1

Asian - Central/South Asian Heritage

2

0

2

Asian - East Asian Heritage

1

2

3

Asian - South East Asian Heritage

3

1

4

Native Hawaiian or Other Pacific Islander

0

1

1

White - White/Caucasian/European Heritage

120

117

237

[1]

Baseline data are reported for participants randomized to the Single- and Multiple-dose Phases (Overall).

Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) [ Time Frame: From the time the participant consented to participate in the study through Visit 28 (Week 25) or the final follow-up visit, for participants who discontinued active participation in the study ]

Number of Participants With Indicated Adverse Events of Special Interest [ Time Frame: From the time the participant consented to participate in the study through Visit 28 (Week 25) or the final follow-up visit, for participants who discontinue active participation in the study ]

Principal Investigators are NOT employed by the organization sponsoring the study.

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the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.